Cleared Traditional

NCB? Polyaxial Locking Plate System; NCB? Periprosthetic Femur Plate System; NCB? Cable Button; NCB? Straight Narrow Shaft Plate

K241754 · Zimmer Switzerland Manufacturing GmbH · Orthopedic

Aug 2024

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K241754 is an FDA 510(k) clearance for the NCB? Polyaxial Locking Plate System; NCB? Periprosthetic Femur Plate System; NCB? Cable Button; NCB? Straight Narrow Shaft Plate, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Zimmer Switzerland Manufacturing GmbH (Winterthur, CH). The FDA issued a Cleared decision on August 15, 2024, 58 days after receiving the submission on June 18, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K241754 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2024
Decision Date	August 15, 2024
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF